21 U.S.C. § 360k
State and local requirements respecting devices
United States · Title 21 — FOOD AND DRUGS · Status: effective
Cite this
- Citation
- 21 U.S.C. § 360k, State and local requirements respecting devices, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454284
- Permanent ID
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Full text
Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if—
the requirement—
Legislative history
The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone.
- Medical Device Amendments of 1976House: no recorded tallySenate: no recorded tally